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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K100994
Device Name PRELOADED TISSUE MARKER DEVICE
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Applicant Contact TINA M WITTCHOW
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Correspondent Contact TINA M WITTCHOW
Regulation Number878.4300
Classification Product Code
NEU  
Date Received04/09/2010
Decision Date 04/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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